Viewing Study NCT00346632

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Ignite Creation Date: 2025-12-24 @ 9:35 PM
Ignite Modification Date: 2025-12-30 @ 7:30 AM
Study NCT ID: NCT00346632
Status: TERMINATED
Last Update Posted: 2024-05-17
First Post: 2006-06-28
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: An Ascending Dose Study of KW-2449 in Acute Leukemias, Myelodysplastic Syndromes, and Chronic Myelogenous Leukemia
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015470', 'term': 'Leukemia, Myeloid, Acute'}, {'id': 'D054198', 'term': 'Precursor Cell Lymphoblastic Leukemia-Lymphoma'}, {'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}, {'id': 'D015464', 'term': 'Leukemia, Myelogenous, Chronic, BCR-ABL Positive'}], 'ancestors': [{'id': 'D007951', 'term': 'Leukemia, Myeloid'}, {'id': 'D007938', 'term': 'Leukemia'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007945', 'term': 'Leukemia, Lymphoid'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C543891', 'term': 'KW 2449'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical.info@kyowakirin.com', 'phone': '6099191100', 'title': 'Project Leader', 'organization': 'Kyowa Kirin Pharmaceutical Development, Inc.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Arm A - 25 mg/Day', 'description': 'KW2449-001 25 mg/day (Treatment Arm A)', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Arm A - 50 mg/Day', 'description': 'KW2449-001 50 mg/day (Treatment Arm A)', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Arm A - 100 mg/Day', 'description': 'KW2449-001 100 mg/day (Treatment Arm A)', 'otherNumAtRisk': 6, 'otherNumAffected': 6, 'seriousNumAtRisk': 6, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': 'Arm A - 200 mg/Day', 'description': 'KW2449-001 200 mg/day (Treatment Arm A)', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'Arm A - 300 mg/Day', 'description': 'KW2449-001 300 mg/day (Treatment Arm A)', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': 'Arm A - 400 mg/Day', 'description': 'KW2449-001 400 mg/day (Treatment Arm A)', 'otherNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Arm A - 500 mg/Day', 'description': 'KW2449-001 500 mg/day (Treatment Arm A)', 'otherNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'seriousNumAffected': 3}, {'id': 'EG007', 'title': 'Arm A - Total', 'description': 'Total Patients in Treatment Arm A', 'otherNumAtRisk': 26, 'otherNumAffected': 26, 'seriousNumAtRisk': 26, 'seriousNumAffected': 19}, {'id': 'EG008', 'title': 'Arm B - 25 mg/Day', 'description': 'KW2449-001 25 mg/day (Treatment Arm B)', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 2}, {'id': 'EG009', 'title': 'Arm B - 50 mg/Day', 'description': 'KW2449-001 50 mg/day (Treatment Arm B)', 'otherNumAtRisk': 4, 'otherNumAffected': 4, 'seriousNumAtRisk': 4, 'seriousNumAffected': 3}, {'id': 'EG010', 'title': 'Arm B - 100 mg/Day', 'description': 'KW2449-001 100 mg/day (Treatment Arm B)', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 3}, {'id': 'EG011', 'title': 'Arm B - Total', 'description': 'Total Patients in Treatment Arm B', 'otherNumAtRisk': 11, 'otherNumAffected': 11, 'seriousNumAtRisk': 11, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 5, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 9, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 9.0'}, {'term': 'Febrile neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 9.0'}, {'term': 'Haemorrhagic diathesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 9.0'}, {'term': 'Leukocytosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 9.0'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 9.0'}, {'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 9.0'}, {'term': 'Splenomegaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 9.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 9.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 9.0'}, {'term': 'Bundle branch block right', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 9.0'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 9.0'}, {'term': 'Sinus tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 9.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 9.0'}, {'term': 'Ventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 9.0'}, {'term': 'Congenital jaw malformation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 9.0'}, {'term': 'Ear haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 9.0'}, {'term': 'Renal failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 9.0'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 9.0'}, {'term': 'Pelvic pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 9.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 9.0'}, {'term': 'Pleural effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 9.0'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 26, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 11, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 9.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety of KW-2449 - Number of Participants With Treatment-related Adverse Events (TEAEs) as Assessed by NCI-CTCAE v3.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '26', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '11', 'groupId': 'OG011'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - 25 mg/Day', 'description': 'KW2449-001 25 mg/day (Treatment Arm A)'}, {'id': 'OG001', 'title': 'Arm A - 50 mg/Day', 'description': 'KW2449-001 50 mg/day (Treatment Arm A)'}, {'id': 'OG002', 'title': 'Arm A - 100 mg/Day', 'description': 'KW2449-001 100 mg/day (Treatment Arm A)'}, {'id': 'OG003', 'title': 'Arm A - 200 mg/Day', 'description': 'KW2449-001 200 mg/day (Treatment Arm A)'}, {'id': 'OG004', 'title': 'Arm A - 300 mg/Day', 'description': 'KW2449-001 300 mg/day (Treatment Arm A)'}, {'id': 'OG005', 'title': 'Arm A - 400 mg/Day', 'description': 'KW2449-001 400 mg/day (Treatment Arm A)'}, {'id': 'OG006', 'title': 'Arm A - 500 mg/Day', 'description': 'KW2449-001 500 mg/day (Treatment Arm A)'}, {'id': 'OG007', 'title': 'Arm A - Total', 'description': 'Total Patients in Treatment Arm A'}, {'id': 'OG008', 'title': 'Arm B - 25 mg/Day', 'description': 'KW2449-001 25 mg/day (Treatment Arm B)'}, {'id': 'OG009', 'title': 'Arm B - 50 mg/Day', 'description': 'KW2449-001 50 mg/day (Treatment Arm B)'}, {'id': 'OG010', 'title': 'Arm B - 100 mg/Day', 'description': 'KW2449-001 100 mg/day (Treatment Arm B)'}, {'id': 'OG011', 'title': 'Arm B - Total', 'description': 'Total Patients in Treatment Arm B'}], 'classes': [{'title': 'Subjects with any TEAE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '5', 'groupId': 'OG006'}, {'value': '26', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '11', 'groupId': 'OG011'}]}]}, {'title': 'Subjects with any serious TEAE', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '19', 'groupId': 'OG007'}, {'value': '2', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '8', 'groupId': 'OG011'}]}]}, {'title': 'Subjects with TEAE related to study drug', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '22', 'groupId': 'OG007'}, {'value': '3', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '9', 'groupId': 'OG011'}]}]}, {'title': 'Subjects with TEAE of Grade 3 or above', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '21', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '3', 'groupId': 'OG009'}, {'value': '3', 'groupId': 'OG010'}, {'value': '7', 'groupId': 'OG011'}]}]}, {'title': 'Subjects who discontinued the study due to TEA', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '0', 'groupId': 'OG011'}]}]}, {'title': 'Subjects who died', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '11', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}, {'value': '1', 'groupId': 'OG011'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Cycle 2, Day 1', 'description': 'In addition to the number of TEAEs, the number of serious TEAEs, the number of related TEAEs, the number of Grade 3-4 TEAEs, and the number of subjects who died or discontinued due to TEAEs were also assessed. The maximally tolerated dose (MTD) was also to be determined, but it was not actually reached in either arm.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Observed Peak Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '5', 'groupId': 'OG013'}, {'value': '4', 'groupId': 'OG014'}, {'value': '4', 'groupId': 'OG015'}, {'value': '4', 'groupId': 'OG016'}, {'value': '4', 'groupId': 'OG017'}, {'value': '4', 'groupId': 'OG018'}, {'value': '4', 'groupId': 'OG019'}, {'value': '3', 'groupId': 'OG020'}, {'value': '3', 'groupId': 'OG021'}, {'value': '3', 'groupId': 'OG022'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - 25 mg/Day: Day 1', 'description': 'KW2449-001 25 mg/day (Treatment Arm A)'}, {'id': 'OG001', 'title': 'Arm A - 25 mg/Day: Day 14', 'description': 'KW2449-001 25 mg/day (Treatment Arm A)'}, {'id': 'OG002', 'title': 'Arm A - 50 mg/Day: Day 1', 'description': 'KW2449-001 50 mg/day (Treatment Arm A)'}, {'id': 'OG003', 'title': 'Arm A - 50 mg/Day: Day 14', 'description': 'KW2449-001 50 mg/day (Treatment Arm A)'}, {'id': 'OG004', 'title': 'Arm A - 100 mg/Day: Day 1', 'description': 'KW2449-001 100 mg/day (Treatment Arm A)'}, {'id': 'OG005', 'title': 'Arm A - 100 mg/Day: Day 14', 'description': 'KW2449-001 100 mg/day (Treatment Arm A)'}, {'id': 'OG006', 'title': 'Arm A - 200 mg/Day: Day 1', 'description': 'KW2449-001 200 mg/day (Treatment Arm A)'}, {'id': 'OG007', 'title': 'Arm A - 200 mg/Day: Day 14', 'description': 'KW2449-001 200 mg/day (Treatment Arm A)'}, {'id': 'OG008', 'title': 'Arm A - 300 mg/Day: Day 1', 'description': 'KW2449-001 300 mg/day (Treatment Arm A)'}, {'id': 'OG009', 'title': 'Arm A - 300 mg/Day: Day 14', 'description': 'KW2449-001 300 mg/day (Treatment Arm A)'}, {'id': 'OG010', 'title': 'Arm A - 400 mg/Day: Day 1', 'description': 'KW2449-001 400 mg/day (Treatment Arm A)'}, {'id': 'OG011', 'title': 'Arm A - 400 mg/Day: Day 14', 'description': 'KW2449-001 400 mg/day (Treatment Arm A)'}, {'id': 'OG012', 'title': 'Arm A - 500 mg/Day: Day 1', 'description': 'KW2449-001 500 mg/day (Treatment Arm A)'}, {'id': 'OG013', 'title': 'Arm A - 500 mg/Day: Day 14', 'description': 'KW2449-001 500 mg/day (Treatment Arm A)'}, {'id': 'OG014', 'title': 'Arm B - 25 mg/Day: Day 1', 'description': 'KW2449-001 25 mg/day (Treatment Arm B)'}, {'id': 'OG015', 'title': 'Arm B - 25 mg/Day: Day 14', 'description': 'KW2449-001 25 mg/day (Treatment Arm B)'}, {'id': 'OG016', 'title': 'Arm B - 25 mg/Day: Day 28', 'description': 'KW2449-001 25 mg/day (Treatment Arm B)'}, {'id': 'OG017', 'title': 'Arm B - 50 mg/Day: Day 1', 'description': 'KW2449-001 50 mg/day (Treatment Arm B)'}, {'id': 'OG018', 'title': 'Arm B - 50 mg/Day: Day 14', 'description': 'KW2449-001 50 mg/day (Treatment Arm B)'}, {'id': 'OG019', 'title': 'Arm B - 50 mg/Day: Day 28', 'description': 'KW2449-001 50 mg/day (Treatment Arm B)'}, {'id': 'OG020', 'title': 'Arm B - 100 mg.Day: Day 1', 'description': 'KW2449-001 100 mg/day (Treatment Arm A)'}, {'id': 'OG021', 'title': 'Arm B - 100 mg/Day: Day 14', 'description': 'KW2449-001 100 mg/day (Treatment Arm B)'}, {'id': 'OG022', 'title': 'Arm B - 100 mg/Day: Day 28', 'description': 'KW2449-001 100 mg/day (Treatment Arm B)'}], 'classes': [{'categories': [{'measurements': [{'value': '6.35', 'spread': '0.754', 'groupId': 'OG000'}, {'value': '7.94', 'spread': '3.06', 'groupId': 'OG001'}, {'value': '10.5', 'spread': '3.49', 'groupId': 'OG002'}, {'value': '18.6', 'spread': '3.10', 'groupId': 'OG003'}, {'value': '34.4', 'spread': '15.7', 'groupId': 'OG004'}, {'value': '38.8', 'spread': '16.1', 'groupId': 'OG005'}, {'value': '31.3', 'spread': '17.8', 'groupId': 'OG006'}, {'value': '83.7', 'spread': '97.4', 'groupId': 'OG007'}, {'value': '97.5', 'spread': '18.6', 'groupId': 'OG008'}, {'value': '147', 'spread': '77.1', 'groupId': 'OG009'}, {'value': '151', 'spread': '52.3', 'groupId': 'OG010'}, {'value': '198', 'spread': '23.3', 'groupId': 'OG011'}, {'value': '180', 'spread': '125', 'groupId': 'OG012'}, {'value': '371', 'spread': '129', 'groupId': 'OG013'}, {'value': '7.05', 'spread': '4.85', 'groupId': 'OG014'}, {'value': '8.39', 'spread': '1.70', 'groupId': 'OG015'}, {'value': '4.49', 'spread': '1.97', 'groupId': 'OG016'}, {'value': '8.20', 'spread': '4.11', 'groupId': 'OG017'}, {'value': '12.7', 'spread': '4.73', 'groupId': 'OG018'}, {'value': '15.6', 'spread': '9.43', 'groupId': 'OG019'}, {'value': '20.9', 'spread': '9.66', 'groupId': 'OG020'}, {'value': '36.3', 'spread': '15.1', 'groupId': 'OG021'}, {'value': '32.5', 'spread': '24.6', 'groupId': 'OG022'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Days 1 and 14 (and Day 28 for Arm B) of Cycle 1', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Peak Plasma Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '3', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}, {'value': '4', 'groupId': 'OG008'}, {'value': '4', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}, {'value': '2', 'groupId': 'OG011'}, {'value': '5', 'groupId': 'OG012'}, {'value': '5', 'groupId': 'OG013'}, {'value': '4', 'groupId': 'OG014'}, {'value': '4', 'groupId': 'OG015'}, {'value': '4', 'groupId': 'OG016'}, {'value': '4', 'groupId': 'OG017'}, {'value': '4', 'groupId': 'OG018'}, {'value': '4', 'groupId': 'OG019'}, {'value': '3', 'groupId': 'OG020'}, {'value': '3', 'groupId': 'OG021'}, {'value': '3', 'groupId': 'OG022'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm A - 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Revised recommendations of the International Working Group for diagnosis, standardization of response criteria, treatment outcomes, and reporting standards for therapeutic trials in acute myeloid leukemia. J Clin Oncol. 2003 Dec 15;21(24):4642-4649.\n\nCheson BD, Bennett JM, Kantarjian H, Pinto A, Schiffer CA, Nimer SD, et al. Report of an international working group to standardize response criteria for myelodysplastic syndromes. Blood. 2000 Dec 1;96(12):3671-3674.\n\nVHA Pharmacy Benefits Management Strategic Healthcare Group and the Medical Advisory Panel. Criteria for use of Imatinib Mesylate (Gleevec®) \\[updated March 2002; cited 2005 Nov 16\\]. 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cycles'}, {'id': 'FG005', 'title': '400 mg/Day KW-2449 14-day Regimen (Arm A)', 'description': 'Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles'}, {'id': 'FG006', 'title': '500 mg/Day KW-2449 14-day Regimen (Arm A)', 'description': 'Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles'}, {'id': 'FG007', 'title': '25 mg/Day KW-2449 28-day Regimen (Arm B)', 'description': 'Arm B has sequential ascending oral doses of KW-2449 given for 28-day cycles'}, {'id': 'FG008', 'title': '50 mg/Day KW-2449 28-day Regimen (Arm B)', 'description': 'Arm B has sequential ascending oral doses of KW-2449 given for 28-day cycles'}, {'id': 'FG009', 'title': '100 mg/Day KW-2449 28-day Regimen (Arm B)', 'description': 'Arm B has sequential ascending oral doses of KW-2449 given for 28-day cycles'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '4'}, {'groupId': 'FG008', 'numSubjects': '4'}, {'groupId': 'FG009', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 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'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Switched to alternative treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Not Stated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Four study centers in the US'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm A: KW-2449 14-day Regimen', 'description': 'Sequential ascending oral doses of KW-2449 given for 14-day cycles'}, {'id': 'BG001', 'title': 'Arm B: KW-2449 28-day Regimen', 'description': 'Sequential ascending oral doses of KW-2449 given for 28-day cycles'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.4', 'spread': '15.48', 'groupId': 'BG000'}, {'value': '62.1', 'spread': '17.22', 'groupId': 'BG001'}, {'value': '61.6', 'spread': '12.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 37}}, 'statusModule': {'whyStopped': 'Terminated due to suboptimal dosing schedule', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-23', 'studyFirstSubmitDate': '2006-06-28', 'resultsFirstSubmitDate': '2016-07-29', 'studyFirstSubmitQcDate': '2006-06-28', 'lastUpdatePostDateStruct': {'date': '2024-05-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-08-02', 'studyFirstPostDateStruct': {'date': '2006-06-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of KW-2449 - Number of Participants With Treatment-related Adverse Events (TEAEs) as Assessed by NCI-CTCAE v3.0', 'timeFrame': 'Baseline up to Cycle 2, Day 1', 'description': 'In addition to the number of TEAEs, the number of serious TEAEs, the number of related TEAEs, the number of Grade 3-4 TEAEs, and the number of subjects who died or discontinued due to TEAEs were also assessed. The maximally tolerated dose (MTD) was also to be determined, but it was not actually reached in either arm.'}], 'secondaryOutcomes': [{'measure': 'Observed Peak Plasma Concentration (Cmax)', 'timeFrame': 'Days 1 and 14 (and Day 28 for Arm B) of Cycle 1'}, {'measure': 'Time to Peak Plasma Concentration (Tmax)', 'timeFrame': 'Days 1 and 14 (and Day 28 for Arm B) of Cycle 1'}, {'measure': 'Area Under the Plasma Concentration-time Curve From 0 to Tau (AUC (0-tau, Tau is the Dosing Interval))', 'timeFrame': 'Days 1 and 14 (and Day 28 for Arm B) of Cycle 1'}, {'measure': 'Terminal Half Life (t 1/2)', 'timeFrame': 'Days 1 and 14 (and Day 28 for Arm B) of Cycle 1'}, {'measure': 'Accumulation Ratio (AUC 0-tau Day 14 or 28 / AUC 0-tau Day 1)', 'timeFrame': 'Day 1 and either Day 14 or Day 28 of Cycle 1'}, {'measure': 'Disease Response', 'timeFrame': 'Day 14 (Arm A) or Day 28 (Arm B) for all cycles', 'description': 'Disease response (i.e., complete or partial remission) based on standard criteria:\n\nCheson BD, Bennett JM, Kopecky KJ, Buchner T, Willman CL, Estey EH, et al. Revised recommendations of the International Working Group for diagnosis, standardization of response criteria, treatment outcomes, and reporting standards for therapeutic trials in acute myeloid leukemia. J Clin Oncol. 2003 Dec 15;21(24):4642-4649.\n\nCheson BD, Bennett JM, Kantarjian H, Pinto A, Schiffer CA, Nimer SD, et al. Report of an international working group to standardize response criteria for myelodysplastic syndromes. Blood. 2000 Dec 1;96(12):3671-3674.\n\nVHA Pharmacy Benefits Management Strategic Healthcare Group and the Medical Advisory Panel. Criteria for use of Imatinib Mesylate (Gleevec®) \\[updated March 2002; cited 2005 Nov 16\\]. Available from: http://www.pbm.va.gov/archive/imatinibcriteria.pdf'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['AML', 'ALL', 'MDS', 'CML', 'Kinase Inhibitor'], 'conditions': ['Acute Myelogenous Leukemia', 'Acute Lymphoblastic Leukemia', 'Myelodysplastic Syndromes', 'Chronic Myelogenous Leukemia']}, 'referencesModule': {'references': [{'pmid': '19029442', 'type': 'DERIVED', 'citation': 'Pratz KW, Cortes J, Roboz GJ, Rao N, Arowojolu O, Stine A, Shiotsu Y, Shudo A, Akinaga S, Small D, Karp JE, Levis M. A pharmacodynamic study of the FLT3 inhibitor KW-2449 yields insight into the basis for clinical response. Blood. 2009 Apr 23;113(17):3938-46. doi: 10.1182/blood-2008-09-177030. Epub 2008 Nov 24.'}]}, 'descriptionModule': {'briefSummary': 'Non-randomized, open, dose ranging and dose scheduling study of ascending doses of KW-2449 in subjects with AML, ALL, MDS and CML.', 'detailedDescription': 'This is a Phase I open-label dose escalation study of KW-2449 in subjects with acute leukemias, high risk MDS, and CML who are not candidates for approved therapy. Over an 18-month period, the investigative sites collectively will enroll up to a total of 96 subjects. Subjects will be enrolled sequentially into 1 of 7 dose groups to evaluate 2 dosing schedules (Arm A = 14 consecutive days of dosing followed by a 7-28 day rest period as determined by recovery from any acute hematologic and non-hematologic toxicities, or Arm B = 28 consecutive days of dosing followed by a 7-28 day rest period, as determined by recovery from any acute hematologic and non-hematologic toxicities). The safety of a dose level in Arm A (14-day dosing regimen) will be established prior to enrollment of subjects in the same dose level in Arm B (28-day dosing regimen).\n\nIn April 2007 the protocol was amended to discontinue Arm B (28 consecutive days of dosing). The protocol will continue as planned for Arm A (14 days of consecutive dosing).\n\nEnrollment will proceed until a maximum tolerated dose (MTD) has been established for each study Arm. Once the MTD has been reached, 12 additional subjects, with 1 or more of the hematologic conditions included in this study, may be enrolled at the MTD as an expanded safety cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Histologically confirmed diagnosis of:\n\n * AML (including APL refractory to all-trans retinoic acid and arsenic) that has relapsed or was not responsive to prior chemotherapy;\n * Relapsed/refractory ALL;\n * CML that has failed to respond or has lost a response to imatinib; and\n * Advanced MDS (INT-2 and High risk by IPSS) with failure or intolerance to approved therapy.\n2. ECOG Performance Status score of 0, 1, or 2;\n3. Male or female, at least 18 years of age;\n4. Signed written informed consent;\n5. Serum creatinine ≤ 2.0 mg/dL;\n6. Serum SGOT (AST) and SGPT (ALT) ≤ 5x ULN; serum bilirubin ≤ 2 mg/dL (serum bilirubin may be ≤ 3.0 mg/dL in any subject with Gilbert's Syndrome); and\n7. For females of childbearing potential, a negative serum pregnancy test. Subjects, of childbearing potential, must use an Investigator-approved method of birth control.\n\nExclusion Criteria:\n\n1. Candidates for approved therapies;\n2. Concomitant treatment with any investigational agent, chemotherapy, radiotherapy, or immunotherapy;\n3. Active CNS leukemia;\n4. Previous or concurrent malignancy except noninvasive non-melanomatous skin cancer, in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least 2 years prior to study entry;\n5. Uncontrolled systemic infection (viral, bacterial, or fungal);\n6. Uncontrollable disseminated intravascular coagulation;\n7. Major surgery within the 28 days preceding the first dose KW-2449;\n8. Radiotherapy, or lack of recovery of any radiotherapy-related acute toxicity, within the 28 days preceding the first dose KW-2449;\n9. Treatment with systemic therapy for the underlying hematologic condition, or lack of recovery of toxicity from such treatment, within 28 days of the first dose of KW-2449, with the following exceptions: hydroxyurea for treatment of hyperleukocytosis (discontinued for at least 48 hours prior to the first dose of KW-2449); imatinib (discontinued for at least 48 hours prior to the first dose of KW-2449); and interferon (discontinued for at least 7 days prior to the first dose of KW-2449);\n10. Treatment with any other investigational agent, or lack of recovery of toxicity from such treatment, within the 28 days preceding the first dose of KW-2449;\n11. Positive serology for HIV;\n12. Clinically significant cardiac dysfunction (New York Heart Association Class 3 or 4) at the time of screening, or a history of myocardial infarction or heart failure within 3 months preceding the first dose of KW-2449;\n13. Any evidence of chronic Graft versus Host Disease;\n14. Active autoimmune disease requiring immunosuppressive therapy;\n15. Female subjects who are pregnant or breast feeding;\n16. Subjects of childbearing potential, unwilling to use an approved, effective means of contraception in accordance with the institution's standards;\n17. Known current drug or alcohol abuse;\n18. Other severe, acute, or chronic medical or psychiatric condition, or laboratory abnormality that may compromise the safety of the subject during the study, affect the subject's ability to complete the study, or interfere with interpretation of study results; or\n19. For any reason is judged by the Investigator to be inappropriate for study participation, including an inability to communicate or cooperate with the Investigator.\n20. Hematopoietic growth factors (i.e., such as erythropoietin or darbepoetin alpha, filgrastim \\[granulocyte colony-stimulating factor {G-CSF }\\], sargramostim \\[granulocyte-macrophage colony-stimulating factor {GM-CSF}\\], or other thrombopoietic agents) and corticosteroids within 14 days of study entry."}, 'identificationModule': {'nctId': 'NCT00346632', 'briefTitle': 'An Ascending Dose Study of KW-2449 in Acute Leukemias, Myelodysplastic Syndromes, and Chronic Myelogenous Leukemia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kyowa Kirin Co., Ltd.'}, 'officialTitle': 'Phase I Safety, Pharmacokinetic, and Pharmacodynamic Study of KW-2449 in Acute Leukemias (AML), Myelodysplastic Syndromes (MDS), and Chronic Myelogenous Leukemia (CML)', 'orgStudyIdInfo': {'id': '2449-US-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KW-2449', 'description': 'Treatment with ascending doses of KW-2449', 'interventionNames': ['Drug: KW-2449']}], 'interventions': [{'name': 'KW-2449', 'type': 'DRUG', 'description': 'Sequential ascending oral doses of KW-2449 given for 14 or 28 days (modified by protocol amendment to only 14 days dosing).', 'armGroupLabels': ['KW-2449']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '08540', 'city': 'Princeton', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Contact Kyowa', 'geoPoint': {'lat': 40.34872, 'lon': -74.65905}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell/New York Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M.D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Matt Fujimori, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kyowa Kirin, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyowa Kirin, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}